[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-totaltoltrazurilcom-684418-05162024":3,"fda-latest-sync-dates":29},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":8,"recipient_title":8,"body_html":18,"body_text":19,"body_fetched_at":20,"medical_device_id":8,"raw":21,"created_at":27,"updated_at":28},1426,"totaltoltrazurilcom-684418-05162024","Warning Letter","totaltoltrazuril.com",null,"Center for Veterinary Medicine","Unapproved New Animal Drug\u002FAdulterated","2024-06-11","2024-05-16","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Ftotaltoltrazurilcom-684418-05162024","684418","Animal & VeterinaryDrugs","Via Email","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">Via Email\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Animal & Veterinary\u003Cbr>Drugs                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\u003C\u002Fdd>\n                    \n            \u003Cdd>totaltoltrazuril.com\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:admin@totaltoltrazuril.com\"> admin@totaltoltrazuril.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Veterinary Medicine\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>May 16, 2024\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>Re: 684418\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>This letter concerns your firm’s marketing of an unapproved new animal drug, Total Toltrazuril - Coccidiosis & Horse EPM Treatment, in violation of the Federal Food Drug and Cosmetic Act (FD&C Act). The United States Food and Drug Administration (FDA) has reviewed your website at the internet address https:\u002F\u002Ftotaltoltrazuril.com\u002F from December 2023 through May 2024, and has determined that you offer this product for sale there.\u003C\u002Fp>\n\n\u003Cp>Based on our review of your website at the internet address https:\u002F\u002Ftotaltoltrazuril.com\u002F, your product is a drug under section 201(g)(1) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)(1)], because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and\u002For intended to affect the structure or any function of the body of an animal. For the reasons described below, this product is an unapproved new animal drug and introducing or delivering this product for introduction into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\u003C\u002Fp>\n\n\u003Cp>You can find the FD&C Act and FDA regulations through links on FDA’s homepage at www.fda.gov.\u003C\u002Fp>\n\n\u003Cp>Examples of claims FDA observed on your website and product labeling that show the intended use of your product include the following:\u003C\u002Fp>\n\n\u003Cp>From your home website at the URL https:\u002F\u002Ftotaltoltrazuril.com\u002F:\u003Cbr>\n• “THE SOLUTION IS TOTAL TOLTRAZURIL! GET THE SOLUTION! …GREAT FOR \u003Cem>All your 4 legged companions\u003C\u002Fem>…”\u003Cbr>\n• “…Toltrazuril is the result of extensive research efforts to help treat EPM (equine protozoal myeloencephalitis) & Coccidiosis. Toltrazuril can be used `as both a preventative and a treatment for disease…”\u003Cbr>\n• “…usually does not require follow-up treatment, even in advanced infections (after three to five days)…”\u003Cbr>\n• “…the efficacy of the drug is independent from the severity of the infection…”\u003Cbr>\n• “…Toltrazuril has a unique mode of action and there is no reason to be concerned with an adverse reaction or a drug-drug reaction. As Toltrazuril only has activity against protozoa, there is no effect on upset of intestinal flora and the formulation is very well tolerated…”\u003Cbr>\n• “…It is recommended to repeat the treatment weekly for a couple of weeks. It is CRITICAL to clean the environment to rid it of coccidia…”\u003Cbr>\n• “…Combats Coccidia Keep your animals safe from Coccidiosis!”\u003Cbr>\n• “…Safe For Use No reported cases of this product ever harming or killing an animal”\u003C\u002Fp>\n\n\u003Cp>From your webpage titled “\u003Cstrong>Total Toltrazuril - Coccidiosis & Horse EPM Treatment\u003C\u002Fstrong>” at the URL https:\u002F\u002Ftotaltoltrazuril.com\u002Fproducts\u002Ftotal-toltrazuril:\u003Cbr>\n• “Total Toltrazuril – Coccidiosis & Horse EPM Treatment”\u003Cbr>\n• “Total Toltrazuril is a preventative and treatment for both coccidiosis and equine protozoal myeloencephalitis (EPM)”\u003C\u002Fp>\n\n\u003Cp>On your social media webpages at the URLs https:\u002F\u002Fwww.facebook.com\u002Fphoto?fbid=650999707226061&set=pb.100069481117087.-2207520000, https:\u002F\u002Fwww.tiktok.com\u002Ft\u002FZT8xN9QR1\u002F and https:\u002F\u002Fwww.instagram.com\u002Ftotaltoltrazuril\u002Fp\u002FC0z17TfMiMm\u002F:\u003Cbr>\n• On your December 13, 2023, Facebook and Instagram posts: “…Total Toltrazuril effectively and safely combats Coccidia and eradicates EPM in your animals…”\u003Cbr>\n• On your November 16, 2023, Facebook post: “…Toltrazuril is safe for a wide variety of animals, including horses, dogs, goats, sheep, chickens, cattle & more…”\u003Cbr>\n• On your November 8, 2023, Facebook post: “…Toltrazuril is the result of extensive research efforts to help treat and prevent EPM and Coccidiosis in animals! …is easy to apply & is safe for your animals…”\u003Cbr>\n• On your November 2, 2023, Facebook post: ”… Our solution acts as both a preventative and treatment against coccidiosis and EPM…”\u003Cbr>\n• On your January 23, 2022, Facebook post: “…Having issues with Coccidia or EPM? We can help! DM for current coupon code! #toltrazuril #totaltoltrazuril #coccidiosis #epm…”\u003Cbr>\n• On your November 8, 2021, Facebook post: “…adult chickens can also be infected with the disease and pass it on to other members of the flock through their droppings. Check our site for toltrazuril as a treatment and preventative…”\u003Cbr>\n• On your October 29, 2021, TikTok post with an infographic that states “…EPM – COCCIDIA – COCCIDIOSIS Are these affecting your animals and CORID is not working? Try our Total Toltrazuril…”\u003C\u002Fp>\n\n\u003Cp>Your product is a new animal drug under section 201(v) of the FD&C Act, [21 U.S.C. 321(v)], because it is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. § 360b, 360ccc, and 360ccc-1]. This product is not approved or index listed by FDA, and therefore, the product is unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of an adulterated drug is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all the requirements of federal law, including FDA regulations.\u003C\u002Fp>\n\n\u003Cp>This letter notifies you of our concerns and provides you an opportunity to address them. Failure to address this matter may lead to legal action without further notice, including, without limitation, seizure and\u002For injunction.\u003C\u002Fp>\n\n\u003Cp>Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.\u003C\u002Fp>\n\n\u003Cp>Please direct your response to U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance by email to CVMUnapprovedDrugs@fda.hhs.gov. Please include “Reference \u003Cstrong>684418\u003C\u002Fstrong>” in the subject line of your email.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Neal Bataller, ME, DVM\u003Cbr>\nDirector\u003Cbr>\nDivision of Drug Compliance\u003Cbr>\nOffice of Surveillance and Compliance\u003Cbr>\nCenter for Veterinary Medicine\u003C\u002Fp>\n\n\u003Cp>Cc: info@totaltoltrazuril.com\u003C\u002Fp>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVia Email\n\nProduct:\n\nAnimal & Veterinary\nDrugs\n\nRecipient:\n\ntotaltoltrazuril.com\n\nUnited States\n\nadmin@totaltoltrazuril.com\n\nIssuing Office:\n\nCenter for Veterinary Medicine\n\nUnited States\n\nWARNING LETTER\n\nMay 16, 2024\n\nRe: 684418\n\nThis letter concerns your firm’s marketing of an unapproved new animal drug, Total Toltrazuril - Coccidiosis & Horse EPM Treatment, in violation of the Federal Food Drug and Cosmetic Act (FD&C Act). The United States Food and Drug Administration (FDA) has reviewed your website at the internet address https:\u002F\u002Ftotaltoltrazuril.com\u002F from December 2023 through May 2024, and has determined that you offer this product for sale there.\n\nBased on our review of your website at the internet address https:\u002F\u002Ftotaltoltrazuril.com\u002F, your product is a drug under section 201(g)(1) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)(1)], because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and\u002For intended to affect the structure or any function of the body of an animal. For the reasons described below, this product is an unapproved new animal drug and introducing or delivering this product for introduction into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\n\nYou can find the FD&C Act and FDA regulations through links on FDA’s homepage at www.fda.gov.\n\nExamples of claims FDA observed on your website and product labeling that show the intended use of your product include the following:\n\nFrom your home website at the URL https:\u002F\u002Ftotaltoltrazuril.com\u002F:\n\n• “THE SOLUTION IS TOTAL TOLTRAZURIL! GET THE SOLUTION! …GREAT FOR All your 4 legged companions…”\n\n• “…Toltrazuril is the result of extensive research efforts to help treat EPM (equine protozoal myeloencephalitis) & Coccidiosis. Toltrazuril can be used `as both a preventative and a treatment for disease…”\n\n• “…usually does not require follow-up treatment, even in advanced infections (after three to five days)…”\n\n• “…the efficacy of the drug is independent from the severity of the infection…”\n\n• “…Toltrazuril has a unique mode of action and there is no reason to be concerned with an adverse reaction or a drug-drug reaction. As Toltrazuril only has activity against protozoa, there is no effect on upset of intestinal flora and the formulation is very well tolerated…”\n\n• “…It is recommended to repeat the treatment weekly for a couple of weeks. It is CRITICAL to clean the environment to rid it of coccidia…”\n\n• “…Combats Coccidia Keep your animals safe from Coccidiosis!”\n\n• “…Safe For Use No reported cases of this product ever harming or killing an animal”\n\nFrom your webpage titled “Total Toltrazuril - Coccidiosis & Horse EPM Treatment” at the URL https:\u002F\u002Ftotaltoltrazuril.com\u002Fproducts\u002Ftotal-toltrazuril:\n\n• “Total Toltrazuril – Coccidiosis & Horse EPM Treatment”\n\n• “Total Toltrazuril is a preventative and treatment for both coccidiosis and equine protozoal myeloencephalitis (EPM)”\n\nOn your social media webpages at the URLs https:\u002F\u002Fwww.facebook.com\u002Fphoto?fbid=650999707226061&set=pb.100069481117087.-2207520000, https:\u002F\u002Fwww.tiktok.com\u002Ft\u002FZT8xN9QR1\u002F and https:\u002F\u002Fwww.instagram.com\u002Ftotaltoltrazuril\u002Fp\u002FC0z17TfMiMm\u002F:\n\n• On your December 13, 2023, Facebook and Instagram posts: “…Total Toltrazuril effectively and safely combats Coccidia and eradicates EPM in your animals…”\n\n• On your November 16, 2023, Facebook post: “…Toltrazuril is safe for a wide variety of animals, including horses, dogs, goats, sheep, chickens, cattle & more…”\n\n• On your November 8, 2023, Facebook post: “…Toltrazuril is the result of extensive research efforts to help treat and prevent EPM and Coccidiosis in animals! …is easy to apply & is safe for your animals…”\n\n• On your November 2, 2023, Facebook post: ”… Our solution acts as both a preventative and treatment against coccidiosis and EPM…”\n\n• On your January 23, 2022, Facebook post: “…Having issues with Coccidia or EPM? We can help! DM for current coupon code! #toltrazuril #totaltoltrazuril #coccidiosis #epm…”\n\n• On your November 8, 2021, Facebook post: “…adult chickens can also be infected with the disease and pass it on to other members of the flock through their droppings. Check our site for toltrazuril as a treatment and preventative…”\n\n• On your October 29, 2021, TikTok post with an infographic that states “…EPM – COCCIDIA – COCCIDIOSIS Are these affecting your animals and CORID is not working? Try our Total Toltrazuril…”\n\nYour product is a new animal drug under section 201(v) of the FD&C Act, [21 U.S.C. 321(v)], because it is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. § 360b, 360ccc, and 360ccc-1]. This product is not approved or index listed by FDA, and therefore, the product is unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of an adulterated drug is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].\n\nConclusion\n\nThis letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all the requirements of federal law, including FDA regulations.\n\nThis letter notifies you of our concerns and provides you an opportunity to address them. Failure to address this matter may lead to legal action without further notice, including, without limitation, seizure and\u002For injunction.\n\nWithin fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.\n\nPlease direct your response to U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance by email to CVMUnapprovedDrugs@fda.hhs.gov. Please include “Reference 684418” in the subject line of your email.\n\nSincerely,\n\n\u002FS\u002F\n\nNeal Bataller, ME, DVM\n\nDirector\n\nDivision of Drug Compliance\n\nOffice of Surveillance and Compliance\n\nCenter for Veterinary Medicine\n\nCc: info@totaltoltrazuril.com","2026-08-20T00:03:20.944+00:00",[22,23,24,9,25,26,26,26],"\u003Ctime datetime=\"2024-06-11T13:20:00Z\">06\u002F11\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-05-16T04:00:00Z\">05\u002F16\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Ftotaltoltrazurilcom-684418-05162024\">totaltoltrazuril.com\u003C\u002Fa>","Unapproved New Animal Drug\u002FAdulterated\u003Cbr \u002F>\r\n","","2026-08-18T06:42:28.856152+00:00","2026-08-20T02:24:56.037289+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"pma":34,"warning_letter":35},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]